Abstract:

This document discusses, among other things, an external device that
includes a communication circuit, a programming interface including a
display, and a processor. The processor includes a parameter analyzer to
apply a rule to a combination of operating parameter values of the IMD to
determine operating parameter interaction. The display includes a first
warning that is displayed when the parameter analyzer determines that a
combination of operating parameter values entered via the programming
interface is not allowed, and a second warning that is displayed when the
parameter analyzer determines that a combination of operating parameters
values entered via the programming interface is allowable but not
recommended. The processor is configured to program the operating
parameter values associated with the second warning into the IMD only
after a user acknowledgement of the second warning is received from a
user via the programming interface.

Claims:

1. A system comprising an external device including:a communication unit
configured to communicate information with an implantable medical device
(IMD);a programming interface including a display; anda processor
communicatively coupled to the communication circuit and the programming
interface, wherein the processor includes:a parameter analyzer configured
to apply a rule to a combination of operating parameter values of the IMD
to determine operating parameter interaction; and wherein:the display
includes a first warning that is displayed when the parameter analyzer
determines that a combination of operating parameter values entered via
the programming interface is not allowed;the display includes a second
warning that is displayed when the parameter analyzer determines that a
combination of operating parameters values entered via the programming
interface is allowable but not recommended; andthe processor is
configured to program the operating parameter values associated with the
second warning into the IMD only after a user acknowledgement of the
second warning is received from a user via the programming interface.

2. The external device of claim 1, wherein the display includes the second
warning that includes text, and wherein the processor is configured to
program the operating parameter values associated with the second warning
into the IMD only after receiving an acknowledgement of the second
warning that indicates the user read the text.

3. The external device of claim 2, wherein the display includes the second
warning that includes educational text concerning a risk to the patient
from the entered combination of operating parameters.

4. The external device of claim 2, wherein text content of at least one of
the first and second warnings is a function of whether the programming
interface is local to or remote from the IMD.

5. The external device of claim 1, wherein the parameter analyzer is
configured to determine that a combination of operating parameter values
is at least one of not allowed or allowable but not recommended using
information about whether the programming interface is local to or remote
from the UMD.

6. The external device of claim 1, wherein the parameter analyzer is
configured to determine that a combination of operating parameter values
is an allowable but not recommended combination of operating parameter
values based on an expected efficacy of a therapy provided by the IMD.

7. The external device of claim 1, wherein the display uses a first color
to display the first warning and a different second color to display the
second warning.

8. The external device of claim 1, wherein the display is configured to
alter display of the operating parameter values associated with the first
warning or the second warning when displaying at least one of the first
warning and the second warning.

9. The external device of claim 1, wherein the display is configured to
inhibit display of the operating parameter values associated with the
first warning or the second warning when displaying at least one of the
first warning and the second warning.

10. The system of claim 1, including a repeater, wherein the repeater
includes a communication circuit configured to communicate information
with the NMD and the external device, andwherein the processor is
configured to display different text with the second warning when the
external device communicates with the NMD via the repeater than when the
external device communicates with the IMD directly.

11. The system of claim 1, including the IMD and a repeater, wherein the
repeater includes a communication unit configured to communicate
information with the IND and the external device, andwherein the
parameter analyzer is configured to categorize a different combination of
operating parameters as being allowable but not recommended when the
external device communicates with the IMD via the repeater than when the
external device communicates with the IND directly.

12. The system of claim 11, wherein the IMD provides a therapy to a
patient, and wherein the parameter analyzer is configured to categorize a
combination of operating parameter values as being allowable but not
recommended when the combination of operating parameter values results in
reduced efficacy of the therapy.

13. The system of claim 12, wherein the NMD includes a therapy unit
configured to provide at least one of bradycardia pacing therapy and
cardioversion/defibrillation therapy, and a detection unit configured to
detect tachyarrhythmia.

14. A method comprising:receiving from a user, at an external device, a
combination of operating parameter values for an implantable medical
device (IMD);applying a rule, using the external device, to the
combination of operating parameter values to determine operating
parameter interaction;displaying a first warning when a disallowed
combination of operating parameter values is received from the
user;displaying a second warning when an allowable but not recommended
combination of operating parameter values is received from the user;
andenabling the combination of operating parameter values associated with
the second level warning to be programmed into the IMD only after
receiving from the user a user acknowledgement of the second warning.

15. The method of claim 14, wherein displaying a second warning includes
displaying text, and wherein receiving the acknowledgement includes
receiving an acknowledgement that the user has read the text.

16. The method of claim 15, wherein displaying the text includes
displaying information concerning risk to the patient resulting from the
combination of operating parameter values associated with the second
warning.

17. The method of claim 15, comprising selecting the text as a function of
whether the external device is local to or remote from the IND.

18. The method of claim 14, comprising selecting the rule as a function of
whether the external device is local to or remote from the ND.

19. The method of claim 14, comprising excluding a combination of
operating parameter values from a recommended set of operating parameter
values based on an expected efficacy of the combination of operating
parameter values.

20. An apparatus comprising:means for receiving from a user, at an
external device, a combination of operating parameter values for an
implantable medical device (IMD);means for applying a rule, using the
external device, to the combination of operating parameter values to
determine operating parameter interaction;means for displaying a first
warning when a disallowed combination of operating parameter values is
received from the user;means for displaying a second warning when an
allowable but not recommended combination of operating parameter values
is received from the user; andmeans for enabling the combination of
operating parameter values associated with the second level warning to be
programmed into the IMD only after receiving from the user a user
acknowledgement of the second warning.

Description:

COPYRIGHT NOTICE

[0001]A portion of the disclosure of this patent document contains
material that is subject to copyright protection. The copyright owner has
no objection to the facsimile reproduction by anyone of the patent
document or the patent disclosure as it appears in the Patent and
Trademark Office patent files or records, but otherwise reserves all
copyright rights whatsoever.

BACKGROUND

[0002]Implantable medical devices (IMDs) include devices designed to be
implanted into a patient. Some examples of these devices include cardiac
function management (CFM) devices such as implantable pacemakers,
implantable cardioverter defibrillators (ICDs), cardiac resynchronization
devices, and devices that include a combination of such capabilities. The
devices can be used to treat patients using electrical or other therapy
or to aid a physician or caregiver in patient diagnosis through internal
monitoring of a patient's condition. The devices may include one or more
electrodes in communication with one or more sense amplifiers to monitor
electrical heart activity within a patient, and often include one or more
sensors to monitor one or more other internal patient parameters. Other
examples of implantable medical devices include implantable diagnostic
devices, implantable drug delivery systems, or implantable devices with
neural stimulation capability.

[0003]Implantable medical devices are able to communicate with external
devices using wireless communication methods such as radio frequency (RF)
or mutual inductance. The external devices are often external programmers
that use wireless communication to change performance parameters in the
implantable device. Such parameters may interact with each other. For
example, programming a first parameter may limit the range of values to
which a second parameter can be programmed. Because of this interaction
between different programmable parameters, a complex set of constraints
typically governs how the set of parameters may be programmed.
Consequently, a physician faces a daunting task in programming the whole
set of parameters to self-consistent values. Moreover, as new therapies
are developed (e.g., congestive heart failure therapies that treat both
left and right sides of the heart), more parameters and more interactions
between parameters are inevitable, further complicating the task of
programming a complete set of parameters to allowable values.

[0004]Often, programming one parameter or a set of parameters to a
particular value yields invalid results when combined with other
interdependent parameter values, causing a complex trial and error
analysis for the user. One method of reducing the difficulty of
programming parameter values is through establishing manufacturer's
default values. This method, however, does not allow the flexibility
needed by the physician to tailor a device to treat a particular patient.

[0005]To program one or more parameters away from the manufacturer
defaults, a user-specified set of parameter values is obtained from the
user, and automatically compared to parameter interaction constraints to
determine whether a constraint violation has occurred. If no constraint
violation exists, the user-specified parameters are accepted into the
programmer for programming into the implantable device. However, if a
constraint violation does exist, the user may be advised of one or more
of the violations. However, it is then typically left to the user to
modify the existing set of parameter values to try to remove the
violation without inadvertently triggering another violation. This can be
a complex process and may decrease the productivity of the user (in most
cases a physician), and increase the possibility of programming errors.

OVERVIEW

[0006]This document relates generally to systems, devices, and methods for
programming an implantable medical device. A system example includes an
external device that includes a communication circuit configured to
communicate information with an IMD, a programming interface including a
display, and a processor communicatively coupled to the communication
circuit and the programming interface. The processor includes a parameter
analyzer to apply a rule to a combination of operating parameter values
of the IND to determine operating parameter interaction. The display
includes a first warning that is displayed when the parameter analyzer
determines that a combination of operating parameter values entered via
the programming interface is not allowed, and a second warning that is
displayed when the parameter analyzer determines that a combination of
operating parameters values entered via the programming interface is
allowable, but is not recommended. The processor is configured to program
the operating parameter values associated with the second warning into
the ND only after a user acknowledgement of the second warning is
received from a user via the programming interface.

[0007]A method example includes receiving from a user, at an external
device, a combination of operating parameter values for an IMD, applying
a rule, using the external device, to the combination of operating
parameter values to determine operating parameter interaction, displaying
a first warning when a disallowed combination of operating parameter
values is received from the user, displaying a second warning when an
allowable but not recommended combination of operating parameter values
is received from the user, and enabling the combination of operating
parameter values associated with the second level warning to be
programmed into the IMD only after receiving from the user a user
acknowledgement of the second warning.

[0008]This overview is intended to provide an overview of subject matter
of the present patent application. It is not intended to provide an
exclusive or exhaustive explanation of the invention. The detailed
description is included to provide further information about the present
patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009]In the drawings, which are not necessarily drawn to scale, like
numerals may describe similar components in different views. The drawings
illustrate generally, by way of example, but not by way of limitation,
various embodiments discussed in the present document.

[0010]FIG. 1 is an illustration of portions of a system that uses an IMD.

[0011]FIG. 2 is an illustration of a system that includes an external
device used to program parameters of an IMD.

[0012]FIG. 3 is a block diagram of an example of a system that includes an
external device to program operating parameters into an IMD.

[0013]FIG. 4 is an illustration of an example of a programming interface
display screen for an external device used to program an IMD.

[0014]FIG. 5 is an illustration of another example of a programming
interface display screen for an external device used to program an IMD.

[0015]FIG. 6 shows a flow diagram of an example of a method of overriding
programming limitations on operating parameters for an IMD.

[0016]FIG. 7 shows a block diagram of another example of a system to
program operating parameters into an IMD.

DETAILED DESCRIPTION

[0017]This document relates to a user interface for a programmer of an
implantable medical device (IMD). To program one or more parameters, a
set of parameter values is obtained from the user and automatically
compared to parameter interaction constraints to determine whether a
constraint violation has occurred. If a constraint violation does exist,
the user may be advised of one or more of the violations.

[0018]Some violations are more serious than others. The more serious
violations are those combinations of parameters that the IMD is not
capable of implementing or those combinations that put a patient's safety
at risk. These combinations of parameter values are not allowed to be
programmed into the IMD. The less serious violations are those
combinations of parameters that are allowed, but are not recommended to
be programmed into the IMD.

[0019]FIG. 1 is an illustration of portions of a system 100 that uses an
implantable medical device (IMD) 105. Examples of IMD 105 include,
without limitation, a, pacemaker, a cardioverter, a defibrillator, a
cardiac resynchronization therapy (CRT) device, and other cardiac
monitoring and therapy delivery devices, including cardiac devices that
include or work in coordination with one or more neuro-stimulating
devices, drugs, drug delivery systems, or other therapies. As one
example, the system 100 shown is used to treat a cardiac arrhythmia. The
IMD 105 typically includes an electronics unit coupled by one or more
cardiac leads 110, 115, 125, to a heart of a patient or subject. The
electronics unit of the IMD 105 typically includes components that are
enclosed in a hermetically-sealed canister or "can." The system 100 also
typically includes an IMD programmer or other external system 190 that
communicates one or more wireless signals 185 with the IMD 105, such as
by using radio frequency (RF) or by one or more other telemetry methods.

[0020]The example shown includes right atrial (RA) lead 110 having a
proximal end 111 and a distal end 113. The proximal end 111 is coupled to
a header connector 107 of the IMD 105. The distal end 113 is configured
for placement in the RA in or near the atrial septum. The RA lead 110 may
include a pair of bipolar electrodes, such as an RA tip electrode 114A
and an RA ring electrode 114B. The RA electrodes 114A and 114B are
incorporated into the lead body at distal end 113 for placement in or
near the atrial septum, and are each electrically coupled to IMD 105
through a conductor extending within the lead body. The RA lead is shown
placed in or near the atrial septum, but the RA lead may be placed in the
atrial appendage or elsewhere.

[0021]The example shown also includes a right ventricular (RV) lead 115
having a proximal end 117 and a distal end 119. The proximal end 117 is
coupled to a header connector 107. The distal end 119 is configured for
placement in the RV. The RV lead 115 may include one or more of a
proximal defibrillation electrode 116, a distal defibrillation electrode
11 8, an RV tip electrode 120A, and an RV ring electrode 120B. The
defibrillation electrode 116 is generally incorporated into the lead body
such as in a location suitable for supraventricular placement in the RA
and/or the superior vena cava. The defibrillation electrode 118 is
incorporated into the lead body near the distal end 119 such as for
placement in the RV. The RV electrodes 120A and 120B may form a bipolar
electrode pair and are generally incorporated into the lead body at
distal end 119. The electrodes 116, 118, 120A, and 120B are each
electrically coupled to IMD 105, such as through one or more conductors
extending within the lead body. The proximal defibrillation electrode
116, distal defibrillation electrode 118, or an electrode formed on the
can of IMD 105 allow for delivery of cardioversion or defibrillation
pulses to the heart.

[0022]The RV tip electrode 120A, RV ring electrode 120B, or an electrode
formed on the can of IMD 105 allow for sensing an RV electrogram
indicative of RV depolarizations and delivering RV pacing pulses. RA tip
electrode 114A, RA ring electrode 114B, or an electrode formed on the can
of IMD 105 allow for sensing an RA electrogram indicative of RA
depolarizations and allow for delivering RA pacing pulses. Sensing and
pacing allows the IMD 105 to adjust timing of the heart chamber
contractions. In some examples, the IMD 105 can adjust the timing of
ventricular contractions with respect to the timing of atrial
contractions by sensing a contraction in the RA and pacing the RV at the
desired atrial-ventricular (AV) delay time.

[0023]A left ventricular (LV) lead 125 can include a coronary pacing or
sensing lead that includes an elongate lead body having a proximal end
121 and a distal end 123. The proximal end 121 is coupled to a header
connector 107. A distal end 123 is configured for placement or insertion
in the coronary vein. The LV lead 125 may include an LV ring or tip
electrode 128A and an LV ring electrode 128B. The distal portion of the
LV lead 125 is configured for placement in the coronary sinus and
coronary vein such that the LV electrodes 128A and 128B are placed in the
coronary vein. The LV electrodes 128A and 128B may form a bipolar
electrode pair and are typically incorporated into the lead body at
distal end 123. Each can be electrically coupled to IMD 105 such as
through one or more conductors extending within the lead body. LV tip
electrode 128A, LV ring electrode 128B, or an electrode formed on the can
of the IMD 105 allow for sensing an LV electrogram indicative of LV
depolarizations and delivering LV pacing pulses.

[0024]Other forms of electrodes include meshes and patches, which may be
applied to one or more portions of heart, or which may be implanted in
one or more other areas of the body to help "steer" electrical current
produced by the IMD 105 in FIG. 1. The IMDs may be configured with a
variety of electrode arrangements or combinations, including transvenous,
endocardial, or epicardial electrodes (e.g., intrathoracic electrodes),
or subcutaneous, non-intrathoracic electrodes, such as can, header, or
indifferent electrodes, or subcutaneous array or lead electrodes (e.g.,
non-intrathoracic electrodes). Monitoring of one or more electrical
signals related to cardiac activity can provide early, if not immediate,
diagnosis of cardiac disease.

[0025]FIG. 2 is an illustration of a system 200 that includes an external
device 205 used to program parameters of an IMD 210. The external device
205 includes a programming interface such as a display 215 and/or a
keyboard 220 or computer mouse. The external device 205 communicates with
the IMD 210 wirelessly.

[0026]FIG. 3 is a block diagram of an example of a system that includes an
external device 300 to program operating parameters into an IMD. The
external device 300 includes a communication unit 305 to communicate
information with the IMD. The communication unit 305 is configured to
facilitate the communication by including any combination of hardware,
firmware, or software. The external device 300 includes a programming
interface 310, which includes a display 315.

[0027]The external device 300 also includes a processor 320
communicatively coupled to the communication unit 305 and the programming
interface 310. The processor 320 may include a digital signal processor,
application specific integrated circuit (ASIC), microprocessor, or other
type of processor, interpreting or executing instructions in software or
firmware.

[0028]The processor 320 includes a parameter analyzer 325 to apply a rule
to a combination of operating parameter values for an IMD to determine
operating parameter interaction. A user typically enters or otherwise
specifies a first set of desired parameter values for the IMD. The rule
applied by the parameter analyzer 325 creates one or more
interdependencies between different programmable parameters using a set
of parameter interaction constraints. These constraints will restrict
which values are acceptable for the user-specified first set of parameter
values. The user specified first set of parameter values is automatically
checked against such constraints to ensure that the user-specified set of
parameter values are acceptable before they are programmed into the IMD.
The AMD manufacturer typically defines such restrictions, such as based
on safe operating conditions for the IMD. Descriptions of systems,
devices, and methods for determining parameter interaction constraints
are found in West et al., U.S. patent application Ser. No. 11/380,570,
"Medical Device User Interface Automatically Resolving Interaction
between Programmable Parameters," filed Apr. 27, 2006 which is
incorporated herein by reference.

[0029]The automatic comparison of the first set of parameter values to the
parameter interaction constraints may result in a first set of one or
more constraint violations. In certain examples, the parameter analyzer
325 uses the constraint violations to categorize combinations of
operating parameters into multiple categories (e.g., those that are not
allowed, those that are allowed but not recommended, and those that are
allowed and result in no constraint).

[0030]The display 315 includes a first warning 330 that is displayed when
a disallowed combination or set of operating parameter values is entered
via the programming interface. A combination of operating parameters is
not allowed when the combination may result in the IMD functioning
incorrectly. For example, if the user tries to program a device lower
rate limit (LRL) greater than the maximum tracking rate (MTR), the
combination is not allowed. A combination of operating parameters is also
not allowed when the parameter analyzer 325 determines that the
combination may put a patient's safety at risk. The processor 320 does
not allow the operating parameters associated with the first warning 330
to be programmed into the IMD.

[0031]The display 315 includes a second warning 335 that is displayed when
an allowable but not recommended combination of operating parameter
values is entered via the programming interface 310. A combination of
operating parameters is allowable but not recommended when the parameter
analyzer 325 determines that the combination may result in a reduction in
expected efficacy of therapy or diagnostics provided by the IMD.

[0032]In certain examples, the first warning 330 includes a display of the
word "error" or "warning," while the second warning 335 includes a
display of the word "attention." In certain examples, the display 315
uses a first color to display the first warning 330 (e.g., red) and a
different second color to display the second warning 335 (e.g., yellow).
In certain examples, the display 315 inhibits the display of the
operating parameter values associated with the first warning or the
second warning when displaying at least one of the first warning and the
second warning. In certain examples, the display 315 alters the display
of the operating parameter values associated with the first warning 330
or the second warning 335 when displaying at least one of the first
warning and the second warning. For instance, the display 315 may "ghost"
or the operating parameter values by displaying the parameters at a lower
intensity.

[0033]The second warning 335 may be overridden. The processor 320 programs
the operating parameter values associated with the second warning 335
into the IMD only after a user acknowledgement of the second warning is
received from a user via the programming interface. Without the
acknowledgement from the user, the operating parameter values associated
with the second warning 335 are treated as not allowed and are not
programmed into the IMD. This programming limitation prevents the user
from pushing past the conflicts in the selected set of operating
parameters until the user overrides the limitation by acknowledging and
accepting the patient risk. In certain examples, the operating parameters
are not displayed until the user acknowledges and accepts the patient
risk. In certain examples, the operating parameters are ghosted until the
user acknowledges and accepts the patient risk.

[0034]According to some examples, the second warning 335 includes text.
The processor 320 programs the operating parameter values associated with
the second warning 335 into the IMD only after receiving an
acknowledgement of the second warning 335 that indicates the user read
the text. The processor 320 may receive the acknowledgement via the
programming interface 310 such as by a keyboard, keypad, touch screen,
computer mouse, or the like. In certain examples, the second warning 335
includes educational text concerning a risk to the patient from the
entered combination of operating parameters.

[0035]FIG. 4 is an illustration of an example of a programming interface
display screen 400 for an external device used to program an IMD. The
example shows a user selecting a Rhythm ID Temporary Lower Rate Limit of
45 pulses per minute (ppm). When a user attempts to program an operating
parameter, a text box 405 containing educational text concerning the IMD
parameter is displayed. The display may include an indication that there
is no risk to the patient caused by the selection. For example, the
display screen 400 may display an OK indication 410. In certain examples
the indication is displayed using a color (e.g., green) different from a
color used to display a violation. Because the selection does not result
in risk or other violation, the user is not required to check a risk
disclaimer box 415 before programming the parameter into the IMD.

[0036]FIG. 5 is an illustration of another example of a programming
interface display screen 500 for an external device used to program an
IMD. The example shows a user selecting a Rhythm ID Temporary Lower Rate
Limit of 95 ppm. A text box 505 containing educational text concerning
the IMD parameter is displayed. The display screen includes a warning 510
that the selection results in a combination of operating parameter values
that are allowable but not recommended. Because the selection may result
in risk to the patient, the user is required to check the risk disclaimer
box 515 before the parameter or parameters are allowed to be programmed
into the IMD.

[0037]For example, the user may be selecting a set of operating parameters
that sacrifices bradycardia pacing for tachyarrhythmia sensing. The text
informs the user of the IMD operation and the user can make an informed
decision about whether to program more pacing at the expense of tachy
sensing, or more tachy sensing with less pacing. The text includes an
explanation of the risk involved in the programming and is displayed at
the time of parameter selection. The user then actively chooses between
the risks involved to provide the best therapy for the patient using
their professional judgment.

[0038]FIG. 6 shows a flow diagram of an example of a method 600 of
overriding programming limitations on operating parameters for an IMD. At
block 605, a combination of operating parameter values for an IMD is
received from a user at an external device. At block 610, using the
external device, a rule is applied to the combination of operating
parameter values to determine operating parameter interaction. At block
615, a first warning is displayed when a disallowed combination of
operating parameter values is received from the user. At block 620, a
second warning is displayed when an allowable but not recommended
combination of operating parameter values is received from the user at
the external device. At block 625, the combination of operating parameter
values associated with the second level warning is enabled to be
programmed into the IMD only after receiving from the user a user
acknowledgement of the second warning.

[0039]According to some examples, the programming interface is remote from
the IMD. FIG. 7 shows a block diagram of another example of a system 700
to program operating parameters into an IMD 710. The system 700 includes
a repeater 730 and an external device 705. The repeater 730 includes a
communication unit 735 configured to communicate information with the IMD
710 and the external device 705. The repeater 730 is local to the IMD
710, such as by being in the same room as the patient for example. In the
example shown, the repeater 730 communicates with the external device 705
via a computer network 740. The external device 705 may access the
computer network 740 through a central server 745. The repeater 730 may
access the computer network 740 through a local computer 750. In certain
examples, the repeater 730 communicates with the external device 705 via
a cell phone network.

[0040]The external device 705 includes a programming interface to program
operating parameters into the IMD 710. In certain examples, the IMD 710
includes a therapy unit 755 configured to provide bradycardia pacing
therapy and/or cardioversion/defibrillation therapy to a patient, and a
detection unit 760 to detect tachyarrhythmia in the patient.

[0041]Returning to the external device 300 of FIG. 3, in some examples,
the parameter analyzer 325 determines that a combination of operating
parameter values is not allowed and/or determines that a combination is
allowable but not recommended using information about whether the
programming interface 310 is local to or remote from the IMD. The
programming interface is local to the IMD when the external device 300
communicates with the IMD directly. The programming interface 310 is
remote from the IMD when the external device 300 communicates with the
IMD using a third device such as the repeater shown in FIG. 7.

[0042]In certain examples, the parameter analyzer 325 may determine that
an operating parameter set selected by a user is not allowed whether
programmed in a clinical setting or programmed remotely. In an
illustrative example, the user may try to set the minimum dynamic
ventricular refractory period plus 90 milliseconds (Min Dynamic VRP+90
ms) greater than the upper rate limit (URL) in ms. Such a combination
places the patient's safety at risk and would not be allowed by the rule
applied by the parameter analyzer 325 whether selected in a clinical
setting or selected remotely.

[0043]In certain examples, the parameter analyzer 325 may determine that
an operating parameter set selected by a user is allowable but not
recommended when in a clinical setting and not allowed when selected
remotely. As an illustrative example, a user may select an operating
parameter set that reduces the right ventricle (RV) pacing amplitude by
25%. Reducing the RV pacing amplitude may result in the IMD not providing
ventricular contractions. This may be allowable in a clinical setting
because the clinician may easily observe whether the programming affects
the patient adversely, such as by causing syncope for example. Thus, the
parameter analyzer 325 identifies a different combination of operating
parameters as being allowable but not recommended when the programming is
in a clinical setting and the external device 300 communicates with the
IMD directly than when the programming is remote. In another illustrative
example, the user selects to extend the atrial-ventricular delay (A-V
Delay) to such an extent that pacing by the IMD is inhibited. This may
also be deemed by the parameter analyzer 325 to be allowable but not
recommended in a clinical setting and not allowed when programmed
remotely.

[0044]In some examples, the first warning 330 and the second warning 335
include text, and the text content is a function of whether the
programming interface is local to the NMD in a clinical setting or remote
from the ND. In the illustrative example above, the first warning
displayed when a user remotely programs a reduced RV pacing amplitude by
25% may include text explaining that the programming is not allowed to
the risk of syncope in the patient. Such text may not be included in the
second warning displayed when the programming is in a clinical setting.

[0045]The clinician is allowed to program the operating parameters after
the external device 300 displays the second warning 335 and the clinician
acknowledges the risk, thereby allowing the clinician to use their
professional judgment in programming the device. Note that because the
same combination of parameters may be allowable in a clinical setting but
not allowed in a remote setting, the constraints determined by the
parameter analyzer 325 may result in more first warnings 330 for a remote
programming session than for a programming session in a clinical setting.

[0046]In certain examples, the parameter analyzer 325 may determine that
an operating parameter combination selected by a user is allowable but
not recommended when selected either remotely or in a clinical setting.
As an illustrative example, a user may select an operating parameter
combination that sets a tachyarrhythmia rate detection zone interval (ms)
greater than the lower rate limit interval (ms) minus the
atrial-ventricular delay (Tachy Rate Zone interval>LRL-AV Delay). Such
an operating parameter set would cause the IMD to provide pacing pulses
within the Tachy Rate Zone and would be allowable but not recommended
whether in a clinical setting or when programming remotely.

[0047]In certain examples, the parameter analyzer 325 may determine that
an operating parameter set selected by a user is allowed when in a
clinical setting and allowable but not recommended when selected
remotely. As an illustrative example, a current set of operating
parameter values may include a LRL of 60 ppm and a user may select to
reduce the LRL by 15%. Because reducing the LRL may compromise efficacy
of the IMD, this selection may be allowed in a clinical setting, but may
be deemed allowable but not recommended when programming remotely. In a
clinical setting the display 315 may display an OK indication. In a
remote programming setting, the user is allowed to program the operating
parameters after the external device 300 displays the second warning 335
and the clinician acknowledges the risk. Note that the constraints
determined by the parameter analyzer 325 may result in more second
warnings 335 for a remote programming session than for a programming
session in a clinical setting.

[0048]Information as to whether the programming interface 310 is local to
or remote from the IND can be furnished by the user or can be obtained by
the external device 300 at the time of the programming. For example, the
external device 300 may transmit a message and a receiving device
identifies itself in a response message. In some examples, the parameter
analyzer 325 includes more than one rule to apply to operating parameters
to determine constraints, and applies a different rule when the external
device 300 is local to the IMD than when the external device is remote
from the external device 300.

[0049]The parameter analyzer 325 identifies parameter interaction
constraints that may result in a first set of one or more constraint
violations. The external device 300 uses the constraints to limit the
combination of operating parameters available to the user. The constraint
violations and thus the combination limits may vary depending on whether
the parameters are being programmed in a local or a remote programming
session. The external device 300 provides a flexible interactive limit
override for the operating parameters. Flexible interactive limit control
improves patient safety and promotes conscious decision making from
physicians when the patient's condition may cause the physician to desire
conflicting device settings.

[0050]The above detailed description includes references to the
accompanying drawings, which form a part of the detailed description. The
drawings show, by way of illustration, specific embodiments in which the
invention can be practiced. These embodiments are also referred to herein
as "examples." All publications, patents, and patent documents referred
to in this document are incorporated by reference herein in their
entirety, as though individually incorporated by reference. In the event
of inconsistent usages between this document and those documents so
incorporated by reference, the usage in the incorporated reference(s)
should be considered supplementary to that of this document; for
irreconcilable inconsistencies, the usage in this document controls.

[0051]In this document, the terms "a" or "an" are used, as is common in
patent documents, to include one or more than one, independent of any
other instances or usages of "at least one" or "one or more." In this
document, the term "or" is used to refer to a nonexclusive or, such that
"A or B" includes "A but not B." "B but not A," and "A and B," unless
otherwise indicated. In the appended claims, the terms "including" and
"in which" are used as the plain-English equivalents of the respective
terms "comprising" and "wherein." Also, in the following claims, the
terms "including" and "comprising" are open-ended, that is, a system,
device, article, or process that includes elements in addition to those
listed after such a term in a claim are still deemed to fall within the
scope of that claim. Moreover, in the following claims, the terms
"first," "second," and "third," etc. are used merely as labels, and are
not intended to impose numerical requirements on their objects.

[0052]Method examples described herein can be machine or
computer-implemented at least in part. Some examples can include a
computer-readable medium or machine-readable medium encoded with
instructions operable to configure an electronic device to perform
methods as described in the above examples. An implementation of such
methods can include code, such as microcode, assembly language code, a
higher-level language code, or the like. Such code can include computer
readable instructions for performing various methods. The code may form
portions of computer program products. Further, the code may be tangibly
stored on one or more volatile or non-volatile computer-readable media
during execution or at other times. These computer-readable media may
include, but are not limited to, hard disks, removable magnetic disks,
removable optical disks (e.g., compact disks and digital video disks),
magnetic cassettes, memory cards or sticks, random access memories
(RAM's), read only memories (ROM's), and the like.

[0053]The above description is intended to be illustrative, and not
restrictive. For example, the above-described examples (or one or more
aspects thereof) may be used in combination with each other. Other
embodiments can be used, such as by one of ordinary skill in the art upon
reviewing the above description. The Abstract is provided to comply with
37 C.F.R. §1.72(b), to allow the reader to quickly ascertain the
nature of the technical disclosure. It is submitted with the
understanding that it will not be used to interpret or limit the scope or
meaning of the claims. Also, in the above Detailed Description, various
features may be grouped together to streamline the disclosure. This
should not be interpreted as intending that an unclaimed disclosed
feature is essential to any claim. Rather, inventive subject matter may
lie in less than all features of a particular disclosed embodiment. Thus,
the following claims are hereby incorporated into the Detailed
Description, with each claim standing on its own as a separate
embodiment. The scope of the invention should be determined with
reference to the appended claims, along with the full scope of
equivalents to which such claims are entitled.